Status:
COMPLETED
A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
Lead Sponsor:
Curis, Inc.
Conditions:
Head and Neck Cancer
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent de...
Eligibility Criteria
Inclusion
- Subjects with histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer.
- For subjects with non-small cell lung cancer only:
- Most recent treatment must be erlotinib and subjects must have had a radiographic partial or complete response to treatment as defined by RECIST criteria and should be currently progressing after the documented response.
- A documented mutation in EGFR exons 19 or 21
- Subjects must have no further standard of care options or have refused standard therapy
- Measurable or evaluable disease
- Age ≥ 18 years
- ECOG performance \< 2
- Life expectancy ≥ 3 months
- If female, neither pregnant or lactating
- If of child bearing potential, must use adequate birth control
- Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
- Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
- Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
- Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
- Serum magnesium and potassium within normal limits (may use supplements to achieve normal values)
- Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
- Able to render informed consent and to follow protocol requirements.
Exclusion
- Anticancer therapy within 4 weeks of study entry.
- Use of investigational agent(s) within 30 days of study entry
- History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
- Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Subjects with liver cancer and hepatitis may be eligible.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01171924
Start Date
July 1 2010
End Date
October 1 2011
Last Update
March 1 2016
Active Locations (7)
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1
San Diego Pacific Oncology and Hematology Associates
Encinitas, California, United States, 92024
2
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
3
Mountain Blue Global Cancer Care
Wheat Ridge, Colorado, United States, 80033
4
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106